Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 104: Dr. Nicholas Vafai, Founder and President, Viro Research
DE Talk | Navigating COVID-19 Vaccine Mandates: Employer vs Employee Rights
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
What device companies need to know ahead of an advisory panel meeting
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more
Last week, the Food and Drug Administration (FDA) authorized a fourth coronavirus vaccination, approving a new shot developed by Novavax. Unlike the Pfizer and Moderna products, this vaccine does not use messenger RNA...more
Yesterday, the FDA authorized a second COVID-19 booster dose for Americans ages 50 and older, along with some immunocompromised individuals, at least four months after their initial booster....more
Last week, Senators Thom Tillis (R-NC), Tom Cotton (R-AR), and Marsha Blackburn (R-TN) sent a letter to Secretary of Commerce Gina Raimondo (at right) to express their "grave concerns with the so called 'compromise' agreement...more
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
In this special episode, Akin Gump labor and employment practice head Bob Lian and partner Lauren Leyden welcome noted epidemiologist Dr. Stephen Ostroff to update listeners on workplace issues related to coronavirus. ...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
As the COVID-19 pandemic continues, employers around the globe will soon face new challenges: will they require employees to be vaccinated? While many are encouraging their workers to get vaccinated, relatively few workplaces...more
It’s hard to keep up with all the recent changes to labor and employment law. While the law always seems to evolve at a rapid pace, there have been an unprecedented number of changes for the past few years—and this past month...more
The coronavirus keeps ripping through the country with a fourth, Delta-variant fueled surge that also is producing confounding, confused behaviors that only add to the pandemic’s considerable gloom. The pandemic, which...more
House Leadership Holds The Line On Dual-Track Infrastructure Bill(s) Strategy. Earlier this week, media concerns abounded that moderate house democrats might throw an immovable wrench in the serious progress with the...more
On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more
The COVID-19 vaccine approval process reached a major milestone, but the fourth U.S. wave of the COVID-19 virus has prompted some sobering projections about the future of the pandemic. COVID-19 Vaccine Receives Full FDA...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more
Over the past year and a half, employers have become all too familiar with various public health agencies and their regulations, recommendations, and preventative measures. For the past several months, a big question for...more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer vaccine for those 16 and older - the first full approval of the three COVID-19 vaccines available in the U.S. The Moderna and Johnson &...more
Yesterday, the U.S. Food and Drug Administration (FDA) granted “full approval” to the Pfizer-BioNTech COVID-19 vaccine for individuals 16 years of age and older. In other words, the Pfizer-BioNTech vaccine (which will now be...more
On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more
Seyfarth Synopsis: Today the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, to prevent COVID-19 disease in individuals 16 and older. This could be big news for those on...more
Due to the recent increase in COVID-19 cases, California officials are recommending that private employers require their employees to be vaccinated against COVID-19 or face regular testing. In an article in the Sacramento...more
The news this morning that the federal government fully approved the Pfizer COVID-19 vaccine could be a pivotal milestone in the fight against the coronavirus – especially when it comes to employers’ role in the battle. After...more
The proportion of employers mandating or considering mandating the COVID-19 vaccine increased nearly four-fold in the past three months, spurred by fears surrounding the Delta variant and the growing confidence that such...more